Zealway GWA Horizontal Double-Door Pulsed Vacuum Steam Sterilizer

Overview

The Zealway GWA Horizontal Double-Door Pulsed Vacuum Steam Sterilizer is an ISO 13485–certified Class B vacuum steam sterilization system engineered for high-throughput, regulatory-compliant terminal sterilization in research laboratories, pharmaceutical QC facilities, and hospital central sterile supply departments (CSSDs). It operates on the validated principle of saturated steam under controlled pressure and temperature, combined with pulsed vacuum cycles to achieve complete air removal—ensuring uniform steam penetration into porous loads, lumened devices, and wrapped instrumentation. Unlike gravity-displacement sterilizers, the GWA employs a multi-pulse vacuum sequence prior to steam injection, enabling reliable sterilization of complex medical devices per EN 285 and ISO 17665-1. Its double-door, wall-mounted configuration supports strict segregation between “dirty” and “clean” zones, fulfilling ISO 15883-1 requirements for decontamination workflow integrity.

Key Features

• Horizontal double-door architecture with interlocked door safety logic—prevents simultaneous opening and ensures physical separation of pre- and post-sterilization areas.
• Pulsed vacuum system with up to 3 vacuum pulses (≤2.5 kPa residual pressure) followed by steam flush cycles, achieving ≥99.9% air removal from hollow instruments and textile packs.
• Microprocessor-controlled sterilization engine with 10.1-inch capacitive touchscreen interface, supporting real-time cycle parameter monitoring, alarm logging, and event-driven data capture.
• Three standard sterilization modes: Textile (121–134 °C), Instrument (132–135 °C), and Liquid (121 °C with slow cooling and pressure-controlled venting) — all compliant with EN 285 Annex A and USP .
• Integrated validation-ready functions: BD test cycle (EN 13060), vacuum leak test (ISO 17665-2), and programmable biological indicator challenge protocols.
• Motor-driven automatic doors with torque-limited actuation and position feedback sensors—eliminates manual force application and enables hands-free operation in gowning environments.
• Password-protected boot sequence and user-level access control (administrator/operator/guest) aligned with FDA 21 CFR Part 11 audit trail requirements for electronic records.

Sample Compatibility & Compliance

The GWA accommodates a broad range of load types including wrapped surgical kits, endoscopes, glassware, culture media bottles (up to 2 L), and polymer-based labware. Its 350 L chamber (600 mm × 1240 mm internal diameter) supports full-standard pallet loading per ISO 11140-1. All sterilization cycles are thermally mapped and validated per ANSI/AAMI ST79:2023 guidelines. The system complies with CE marking under Medical Device Regulation (MDR) 2017/745, meets ASME BPVC Section VIII Div. 1 pressure vessel standards, and includes factory-installed Class 5 chemical integrators and optional Class 6 process challenge devices (PCDs). Documentation packages include IQ/OQ/PQ templates, traceable calibration certificates for PT100 temperature sensors (±0.25 °C accuracy), and pressure transducer verification reports.

Software & Data Management

Embedded firmware supports USB export of full-cycle logs (timestamp, temperature, pressure, vacuum level, phase duration, alarms) in CSV format. Optional Ethernet or RS485 connectivity enables integration with laboratory information management systems (LIMS) or MES platforms via Modbus TCP. Audit trails record all operator actions—including program edits, parameter overrides, and door status changes—with immutable timestamps and user ID attribution. Data retention exceeds 10,000 cycles; archived logs are digitally signed and compatible with GLP/GMP electronic record retention policies. Remote diagnostics and firmware updates are supported through secure HTTPS portal access.

Applications

• Terminal sterilization of reusable surgical instruments and implantable device components in university hospitals and contract manufacturing organizations (CMOs).
• Pre-sterilization of cell culture consumables (e.g., flasks, pipette tips, bioreactor parts) in biotechnology R&D labs requiring ISO 5 cleanroom-compatible workflows.
• Batch sterilization of liquid media (e.g., LB broth, PBS buffers) with programmable cooling ramp profiles to prevent boil-over and thermal degradation.
• Validation support for ISO 13485 quality systems, including routine requalification per AAMI TIR12 and annual performance verification.
• Cross-departmental sterilization hub deployment—enabling shared infrastructure between microbiology, pathology, and animal facility units while maintaining chain-of-custody integrity.

FAQ

What vacuum level does the GWA achieve during pulsed evacuation cycles?

The system achieves a minimum residual pressure of ≤2.5 kPa across three consecutive vacuum pulses, verified by calibrated absolute pressure transducers traceable to NIST standards.
Can the GWA sterilize liquids in sealed containers without rupture?

Yes—its liquid cycle incorporates controlled pressure ramping, extended dwell time at 121 °C, and gradual depressurization with steam-saturated cooling to prevent container failure and superheating.
Is the touchscreen interface compliant with IEC 62304 software lifecycle requirements?

Yes—the embedded control software is developed and validated per IEC 62304 Class B, with full traceability from requirements to test cases and version-controlled firmware releases.
How is door interlocking enforced for safety compliance?

Dual redundant limit switches and PLC-based door state monitoring ensure mechanical and electrical interlock integrity; simultaneous door opening is physically and logically prohibited per EN 61000-6-2 and ISO 14119.
Does the GWA support third-party validation services?

Zealway provides documented validation protocols, as-built drawings, and factory acceptance test (FAT) reports—enabling seamless collaboration with qualified external validation partners accredited to ISO/IEC 17025.